Diagnosis of Acute Respiratory Syndrome Coronavirus 2 Infection by Detection of Nucleocapsid Protein

Bo Diao; Kun Wen; Jian Chen; Yueping Liu; Zilin Yuan; Chao Han; Jiahui Chen; Yuxian Pan; Li Chen; Yunjie Dan; Jing Wang; Yongwen Chen; Guohong Deng; Hongwei Zhou; Yuzhang Wu

The copyright holder for this preprint (which was not peer-reviewed) is . https://doi.org/10.1101/2020.03.07.20032524 doi: medRxiv preprint evaluation clinical trial with the nucleic acid test as the golden standard, we found that the nucleic acid test positive rate was 87% and 64%，depending on the CT value , the positive rate of N antigen detection of SARS-CoV-2 was 59 % and 63% separately, 100% of nucleocapsid protein positive and negative participants accord with nucleic acid test. However, N antigen detection achieved a sensitivity of 100%, which greatly reduced the false positive rate of nucleic acid detection. More importantly, the earliest patient after 3 days of fever can be identified by the method. Those findings indicate that our N antigen assay is an accurate, rapid, early and simple diagnosis method of COVID-19. It implies that this N antigen detection method not only guarantee early diagnosis in hospitals, and can also be used large-scale screening in community.